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NCT07197723Recruiting

Study of How People Make Decisions About Prostate Cancer Risk

Effect of Polygenic Risk Modifiers on Decisions of BRCA1/2 Mutation Carriers at Risk for Prostate Cancer

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to learn how people with BRCA1/2 mutations respond to genetic risk modifier testing. The researchers will learn more about how people make choices about their health care, including about methods to screen for prostate cancer. Researchers are also doing this study to learn about how the genetic risk modifier test affects people's thoughts and feelings.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
25 Sept 2025
Start date
25 Sept 2025
Primary completion date
Sept 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT07197723

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 25 Sept 2025 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any patient who has had a prostate biopsy within 36 months, according to clinician note (for individuals not presently receiving care at the study site, this information will be based on self-report)

Other illness

  • Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
  • Under active treatment for a malignancy. (Patients are eligible if they have a prior history of malignancy other than prostate cancer, as long as they are not currently undergoing active treatment for the malignancy) (for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report
  • Patients with a known pathogenic and/or likely pathogenic germline variant in any hereditary prostate cancer risk gene, excluding BRCA1 and/or BRCA2, including but not limited to: HOXB13, ATM, CHEK2, NBN, PALB2, MLH1, MSH2, MSH6, PMS2,RAD51C, RAD51D and TP53.

Other

  • Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.

Who the study is looking for

  • Documentation of Disease
    • o Patients must not have prostate cancer (for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Age between 45 - 70;
  • Assigned male sex at birth for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Completed full sequence or targeted genetic testing with a result confirmed in a clinically approved laboratory showing a BRCA1/2 likely pathogenic or pathogenic variant identified, or clinician note documents a BRCA1/2 likely pathogenic or pathogenic variant
  • English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.(for individuals not presently receiving care at the study site, this information will be based on self-report.)

Age in the registry: 45 years to 70 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.